BASIC CARE MICONAZOLE 3- miconazole nitrate cream

United States - English - NLM (National Library of Medicine)

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Active ingredient:
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)
Available from:
L. Perrigo Company
Administration route:
VAGINAL
Prescription type:
OTC DRUG
Therapeutic indications:
Vaginal antifungal if you have never had a vaginal yeast infection diagnosed by a doctor taking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur
Authorization status:
Abbreviated New Drug Application
Authorization number:
0113-7070-14

BASIC CARE MICONAZOLE 3- miconazole nitrate cream

L. Perrigo Company

----------

Amazon Miconazole 3 Drug Facts

Active ingredient

Miconazole nitrate 4% (200 mg in each applicator)

Purpos e

Vaginal antifungal

Us es

Warnings

For vaginal use only

Do not use

if you have never had a vaginal yeast infection diagnosed by a doctor

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

taking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur

When using this product

Stop use and ask a doctor if

treats vaginal yeast infections

vaginal itching and discomfort for the first time

lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling

vaginal discharge. You may have a more serious condition.

vaginal yeast infections often (such as once a month or 3 in 6 months). You could be pregnant or

have a serious underlying medical cause for your symptoms, including diabetes or a weakened

immune system.

been exposed to the human immunodeficiency virus (HIV) that causes AIDS

do not use tampons, douches, spermicides or other vaginal products. Condoms and diaphragms

may be damaged and fail to prevent pregnancy or sexually transmitted diseases (STDs).

do not have vaginal intercourse

mild increase in vaginal burning, itching or irritation may occur

if you do not get complete relief ask a doctor before using another product

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

Other information

Inactive ingredients

benzoic acid, cetyl alcohol, isopropyl myristate, polysorbate 60, potassium hydroxide, propylene

glycol, purified water, stearyl alcohol

Questions or comments?

1-800-719-9260

Consumer Information

3-Day Treatment

CONSUMER INFORMATION LEAFLET

Miconazole Nitrate Vaginal Cream (4%)

VAGINAL ANTIFUNGAL

Cures Most Vaginal Yeast Infections

Why should I use this product?

This product contains 4% miconazole nitrate cream in prefilled applicators that cures most vaginal yeast

infections. Do not use this product if this is the first time you have vaginal discharge, itching, burning and

symptoms do not get better in 3 days

symptoms last more than 7 days

you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling

vaginal discharge

before using this product read the enclosed consumer information leaflet for complete directions

and information

adults and children 12 years of age and over:

insert 1 applicatorful into the vagina at bedtime for 3 nights in a row. Throw applicator away after

use.

children under 12 years of age: ask a doctor

do not use if printed applicator wrapper is torn, open, or incompletely sealed

do not purchase if carton is open

store at 20°-25°C (68°-77°F)

discomfort. See your doctor or health professional first to find out the cause of your symptoms. If a doctor

has told you in the past that you had a vaginal yeast infection and you have the same symptoms now (such

as vaginal discharge, itching or burning), then this product may work for you.

What is a vaginal yeast infection?

A vaginal yeast infection is a common condition caused by an overgrowth of yeast (Candida) that may

normally live in the vagina. Your doctor may call this infection "monilia" or "candidiasis." Some women

may have a yeast infection on the skin outside of the vagina (vulva) at the same time that they have a

vaginal infection.

Who can get a vaginal yeast infection?

You can get a vaginal yeast infection at any age. It is most common during the childbearing years.

Women who are pregnant or diabetic, taking antibiotics, birth control pills or steroids, or who have a

weakened immune system are more likely to get repeated yeast infections that may not clear up easily

with proper treatment.

Some medical conditions can weaken the body's normal ability to fight infection. One of the most

serious of these conditions is infection with the human immunodeficiency virus (HIV - the virus that

causes AIDS). The HIV virus causes the body to be more likely to get infections, including vaginal

yeast infections that may not clear up easily with proper treatment. If you may have been exposed to HIV

and get repeated vaginal yeast infections, you should see your doctor right away. For more information

on HIV infection, please contact your doctor or the CDC National AIDS HOTLINE. The CDC phone

numbers are: 1-800-232-4636 (English/Spanish), or 1-888-232-6348 (hearing impaired, TTY).

How can I tell if I have a vaginal yeast infection?

When you have a vaginal yeast infection, you may have one or more of the following symptoms:

Note: Vaginal yeast infections do NOT cause fever, chills, lower abdominal, back or shoulder

pain, foul-smelling vaginal discharge, or a missed period. These may be signs of a sexually

transmitted disease (STD) or a tubal pregnancy. If you have these symptoms, call your doctor

right away.

What are other causes of a vaginal discharge?

It is normal to have a small amount of vaginal discharge at certain times of the month. This normal

discharge may be clear or slightly white and does not cause itching, pain or a foul odor.

The most common cause of an abnormal vaginal discharge is an infection. These infections include

bacterial vaginosis (BV), trichomoniasis (Trich), gonorrhea (GC) and/or chlamydia. All of these may be

transmitted sexually and are called sexually transmitted diseases (STDs). If you have more questions

about sexually transmitted diseases (STDs) call the CDC Hotline at 1-800-232-4636.

Although many of the infections mentioned above can cause symptoms similar to a vaginal yeast

infection (vaginal discharge, irritation and itching), their diagnosis must be made by a doctor so that

proper treatment can be given.

If these infections are not properly treated or if proper treatment is delayed, serious problems, such as

pelvic inflammatory disease (PID) may result, which may prevent you from having children in the future.

If you are pregnant and do not get the proper treatment, the infection may be passed to your baby before

vaginal itching

vaginal discharge that may be thick, white, and lumpy like cottage cheese

vaginal soreness, irritation, or burning

rash or redness on the skin outside the vagina (vulva)

burning on urination

painful vaginal intercourse (sex)

or during delivery and may cause your baby to have permanent damage. If you have multiple sex partners

or a new sex partner, you should also ask a doctor before use to make sure you do not have an STD.

Why do women get repeated vaginal yeast infections?

Women may get repeated vaginal yeast infections that may not clear up easily with proper treatment.

Listed below are some of the causes of repeated yeast infections:

If you get vaginal yeast infections often (such as once a month or 3 in 6 months), you should talk

to a doctor.

Are vaginal yeast infections sexually transmitted?

Vaginal yeast infections are usually not spread by having intercourse (sex). However, if your partner

has a rash, itching or discomfort in his genital area, he should contact a doctor to find out the cause of

his symptoms and tell the doctor that you are treating your vaginal yeast infection with this product.

How can I prevent repeated vaginal yeast infections?

To lower your chances of getting another yeast infection:

(1) Wear cotton underwear and loose-fitting clothes.

(2) Change out of damp clothes or a wet bathing suit as soon as possible.

(3) If you use minipads when you are not having a menstrual period, change the minipads often.

Can I use this product during my menstrual period?

Yes, this product can be used during your menstrual period. In fact, many women get vaginal yeast

infections just before their period because of hormonal changes. Using this product during your period

will not affect how well this product works. If you have started treatment and your period occurs, you

should complete the full course of treatment.

Do not use tampons while using this product, because tampons may remove some of the drug from the

vagina. Use deodorant-free sanitary napkins or pads instead, and change them often.

hormonal changes occurring a few days before the monthly period

use of antibiotics

use of some birth control pills

pregnancy

diabetes ("sugar" or "high blood sugar")

clothing - wearing tight layers or moist clothing in the genital area

weakened immune system - some drugs (such as chemotherapy or steroids) and medical

conditions can weaken the body's normal ability to fight infection. One of the most serious of

these conditions is infection with the human immunodeficiency virus (HIV - the virus that causes

AIDS). Infection with HIV causes the person to be more likely to get infections, including vaginal

yeast infections.

Try to keep the genital area cool and dry. Yeast grow well in warm, moist areas. The following

suggestions may be helpful:

Talk with your doctor about any drugs you are now taking. You are more likely to get a

vaginal yeast infection if you are taking certain drugs such as antibiotics, steroids, or birth control

pills. Do not stop taking these drugs without first asking your doctor. A doctor may need to see

you to make sure that you do not have other medical conditions such as diabetes or a weakened

immune system.

Can I use other vaginal products with this product?

This drug should not be used with other vaginal products.

How can I get the best results when treating my infection?

What warnings should I know about when using this product?

For vaginal use only.

Do not use if you have never had a vaginal yeast infection diagnosed by a doctor.

Ask a doctor before use if you have:

Ask a doctor or pharmacist before use if you are taking the prescription blood thinning medicine,

warfarin (coumadin), because bleeding or bruising may occur.

When using this product:

Douches and tampons may remove some of the cream from the vagina.

Spermicides may interfere with this product.

Condoms and diaphragms may be damaged by this product and fail to prevent pregnancy or

sexually transmitted diseases (STDs).

Use 1 prefilled applicator of vaginal cream at bedtime, even during your menstrual period for 3

nights in a row.

Dry the genital area thoroughly after a shower, bath or swim. Change out of a wet bathing suit or

damp clothes as soon as possible. A dry area is less likely to lead to the overgrowth of yeast.

Wear cotton underwear and loose-fitting clothes.

Wipe from front to back after a bowel movement or after urination.

Do not douche, because douching may wash the drug out of the vagina.

Do not use tampons, because they remove some of the drug from the vagina. Use deodorant-free

sanitary napkins or pads as needed.

Do not use spermicides, as they may interfere with this product.

Do not have vaginal intercourse while using this product.

Do not scratch the skin outside the vagina. Scratching can cause more irritation and can spread the

infection.

Tell your doctor about any drugs you are now taking. Certain drugs such as antibiotics,

steroids, and birth control pills, may make it more likely for you to get a vaginal yeast infection. If

you are taking any of these drugs do not stop taking them without first asking a doctor.

If you have any other medical questions or concerns about vaginal yeast infections, call your

doctor.

vaginal itching and discomfort for the first time. You may need a different treatment.

lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling

vaginal discharge. You could have a more serious condition.

vaginal yeast infections often (such as once a month or 3 in 6 months). You could be pregnant or

have a serious underlying medical cause for your symptoms, including diabetes or a weakened

immune system.

been exposed to the human immunodeficiency virus (HIV) that causes AIDS.

do not use tampons, douches, spermicides, or other vaginal products. Condoms and diaphragms

may be damaged and fail to prevent pregnancy or sexually transmitted diseases (STDs).

How Should I Use This Product?

This product is for adults and children 12 years of age and over. For children under 12 years, ask a

doctor.

Directions for using the Applicator containing the Vaginal Cream:

Begin treatment before going to bed:

1 Remove the prefilled applicator from the wrapper.

2 Unscrew and remove violet cap from prefilled applicator.

3 Insert plunger into prefilled applicator by placing small end of plunger into the ribbed end of the

applicator.

4 Gently insert the applicator into the vagina as far as it will go comfortably. This can be done while

lying on your back with your knees bent (as shown in the picture) or while standing with your feet apart

and your knees bent.

5 With one hand holding the barrel, use the other hand to push the plunger all the way in to place the

cream as far back in the vagina as possible. Then remove both parts of the applicator from the vagina.

6 Throw the applicator away after use. Do not flush in toilet.

7 Lie down as soon as possible after inserting the cream. This will reduce leakage.

8 Repeat steps 1 through 7 before going to bed for the next 2 days.

You may want to use deodorant-free pads or pantyshields to protect your clothing during the time that

you are using this product. This is because the cream can leak or you may get some discharge. Do not

use tampons, douches, spermicides, condoms or diaphragms until after you have completed

treatment and your symptoms are gone.

do not have vaginal intercourse

mild increase in vaginal burning, itching or irritation may occur

if you do not get complete relief ask a doctor before using another product

Stop use and ask your doctor if:

These may be signs that this product is not working, or you may have a more serious condition or an

allergic reaction.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right

away (1-800-222-1222).

What side effects may occur with this product?

A mild increase in vaginal burning, itching, or irritation may occur when the applicator containing the

cream is inserted. Abdominal cramping has also been reported.

Stop using this product and consult your doctor if you have abdominal pain, hives, skin rash, or if you

have severe vaginal burning, itching, or irritation or swelling.

What should I do if I have questions about this product?

If you have questions of a medical nature, please contact your pharmacist, doctor or health care

professional. If you have any other questions or need more information on this product, call our toll-

free number 1-800-719-9260.

Other Information:

Active Ingredient: miconazole nitrate 4% (200 mg per applicator)

Inactive Ingredients: benzoic acid, cetyl alcohol, isopropyl myristate, polysorbate 60, potassium

hydroxide, propylene glycol, purified water, stearyl alcohol.

Distributed By

Perrigo®

Allegan, MI 49010

10/16

: 07000 00 J1

Package/Label Principal Display Panel

Compare to Monistat

3 active ingredient

3-Day Treatment

3 Prefilled Applicators

Compare to Monistat

3 active ingredient

3-Day Treatment

miconazole 3

symptoms do not get better in 3 days

symptoms last more than 7 days

you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling

vaginal discharge.

TAMPER-EVIDENT UNIT – do not use if printed applicator wrapper is torn, open or

incompletely sealed.

store at 20°-25°C (68°-77°F)

Miconazole Nitrate Vaginal Cream (4%)

Vaginal Antifungal

CURES Most Vaginal YEAST INFECTIONS

Yeast Infection Relief

(Miconazole Nitrate 200 mg per Applicator)

NET WT. 0.18 OZ (5g) EACH APPLICATOR

BASIC CARE MICONAZOLE 3

miconazole nitrate cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 113-70 70

Route of Administration

VAGINAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

MICO NAZO LE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0 D7S5M)

MICONAZOLE NITRATE

40 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

BENZO IC ACID (UNII: 8 SKN0 B0 MIM)

CETYL ALCO HO L (UNII: 9 36 JST6 JCN)

ISO PRO PYL MYRISTATE (UNII: 0 RE8 K4LNJS)

PO LYSO RBATE 6 0 (UNII: CAL22UVI4M)

L. Perrigo Company

PO TASSIUM HYDRO XIDE (UNII: WZH3C48 M4T)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

WATER (UNII: 0 59 QF0 KO0 R)

STEARYL ALCO HO L (UNII: 2KR8 9 I4H1Y)

Product Characteristics

Color

WHITE (to o ff white)

S core

S hap e

S iz e

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 113-70 70 -14

3 in 1 CARTON

11/0 7/20 18

1

5 g in 1 APPLICATOR; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 9 136 6

11/0 7/20 18

Labeler -

L. Perrigo Company (006013346)

Revised: 4/2019

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